Cabaletta Bio
Cabaletta Bio works on 6 rare diseases tracked on Trial Friend, including Dermatomyositis, Lupus Nephritis, Multiple Sclerosis and 3 more, with 5 recruiting clinical trials.
Cabaletta Bio is a Philadelphia cell therapy company applying a borrowed idea to a new problem: the CD19 CAR-T approach that transformed blood cancers, redirected at autoimmune disease. Its lead therapy, rese-cel (resecabtagene autoleucel), is a one-time infusion of a patient's own engineered T cells designed to deplete the B cells driving autoimmune attack, with the goal of resetting the immune system rather than suppressing it indefinitely.
The RESET clinical program spans several of the most stubborn autoimmune diseases: myositis (including dermatomyositis), systemic sclerosis, lupus, generalized myasthenia gravis, and pemphigus vulgaris. Myositis leads the way. After FDA alignment on registrational cohorts and a Regenerative Medicine Advanced Therapy designation, Cabaletta plans a rese-cel BLA submission in 2027, which would put it among the first companies to bring CAR-T to an autoimmune disease.
Data presented through 2026 covered more than 50 treated patients across myositis, lupus, and systemic sclerosis, including the first juvenile dermatomyositis patient and early experience giving rese-cel without preconditioning chemotherapy, a step toward making cell therapy gentler and more practical outside academic centers.
Cabaletta Bio Drug Pipeline
Cabaletta Bio has 5 active clinical trials across 2 development stages, with 5 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.
Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.
Cabaletta Bio Clinical Trials (5)
Active and recruiting clinical trials sponsored by Cabaletta Bio, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.
Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.
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FDA-Approved Drugs
Cabaletta Bio Trial Locations
Cabaletta Bio clinical trials are running at 101 sites in 6 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.
Rare Disease Focus Areas (6)
Diseases targeted by Cabaletta Bio's clinical trial and drug development programs
Dermatomyositis is a rare autoimmune inflammatory disease causing muscle weakness and distinctive skin rashes, particularly over joints. It involves inflammation of muscles and skin blood vessels. Abo...
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE), in which the immune system attacks the kidneys' filters and, without treatment, can lead to kidney failure.
Multiple sclerosis is a chronic autoimmune disease where the immune system attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord. This disrupts communication betwe...
Myasthenia gravis is a chronic autoimmune neuromuscular disorder causing muscle weakness and rapid fatigue. Antibodies attack acetylcholine receptors at the neuromuscular junction, preventing proper m...
Pemphigus Vulgaris is a rare, potentially life-threatening autoimmune blistering disorder where the body produces antibodies against cell-to-cell adhesion molecules, causing blisters and erosions in t...
Systemic sclerosis (scleroderma) is a rare autoimmune disease in which the immune system triggers scarring (fibrosis) of the skin and internal organs while also damaging small blood vessels. It can ha...
Patient Resources
Organizations and resources related to Cabaletta Bio's rare disease focus areas
Frequently Asked Questions About Cabaletta Bio
Common questions about Cabaletta Bio's rare disease programs, clinical trials, and treatments.